SUPER TORQUE 532598CRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705032012041), received between Aug 30, 2018 and Sep 8, 2025 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Degraded; Degraded

  AS REPORTED, THE 5F 65CM 8 SIDEHOLE (SH) SUPER TORQUE MARKER BAND (MB) FLUSH CATHETER WAS FOUND TO BE DISINTEGRATING. ANOTHER CATHETER IN THE PACKAGE SHOWED VISIBLE DAMAGE AT THE HUB. TWO IMAGES WERE RECEIVED FOR REVIEW: ONE SHOWING THE PRODUCT LABELING AND THE OTHER SHOWING THE PROXIMAL PORTION OF A CATHETER INSIDE THE PACKAGING WITH THE STRAIN RELIEF APPEARING CRACKED AND PORTIONS OF IT MISSING. THERE WERE NO REPORTS OF PATIENT INJURY. IN SUM, 2 OUT OF THE 4 CATHETERS BEING RETURNED HAD THE SAME ISSUES. NONE OF THE CATHETERS WERE USED ON THE PATIENT; ONE WAS OPENED, AND DISINTEGRATION WAS NOTICED BEFORE ACTUAL USE. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO REPORTS OF PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE USER PULLED ALL LOT NUMBERS FROM THE SHELF AND IS SENDING BACK A TOTAL OF FOUR CATHETERS FOR EVALUATION. ADDENDUM: PER PRELIMINARY PE FINDINGS, ONE STERILE CATHETER WAS OBSERVED TO HAVE A DEGRADATION CONDITION AND A YELLOWISH COLOR AND ANOTHER STERILE CATHETER WAS FOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994374 ↗
• MalfunctionJul 15, 2025Degraded; Degraded

  AS REPORTED, THE 5F 65CM 8 SIDEHOLE (SH) SUPER TORQUE MARKER BAND (MB) FLUSH CATHETER WAS FOUND TO BE DISINTEGRATING. ANOTHER CATHETER IN THE PACKAGE SHOWED VISIBLE DAMAGE AT THE HUB. TWO IMAGES WERE RECEIVED FOR REVIEW: ONE SHOWING THE PRODUCT LABELING AND THE OTHER SHOWING THE PROXIMAL PORTION OF A CATHETER INSIDE THE PACKAGING WITH THE STRAIN RELIEF APPEARING CRACKED AND PORTIONS OF IT MISSING. THERE WERE NO REPORTS OF PATIENT INJURY. IN SUM, 2 OUT OF THE 4 CATHETERS BEING RETURNED HAD THE SAME ISSUES. NONE OF THE CATHETERS WERE USED ON THE PATIENT; ONE WAS OPENED, AND DISINTEGRATION WAS NOTICED BEFORE ACTUAL USE. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO REPORTS OF PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE USER PULLED ALL LOT NUMBERS FROM THE SHELF AND IS SENDING BACK A TOTAL OF FOUR CATHETERS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507074 ↗
• MalfunctionJul 15, 2025Degraded; Degraded

  AS REPORTED, THE 5F 65CM 8 SIDEHOLE (SH) SUPER TORQUE MARKER BAND (MB) FLUSH CATHETER WAS FOUND TO BE DISINTEGRATING. ANOTHER CATHETER IN THE PACKAGE SHOWED VISIBLE DAMAGE AT THE HUB. TWO IMAGES WERE RECEIVED FOR REVIEW: ONE SHOWING THE PRODUCT LABELING AND THE OTHER SHOWING THE PROXIMAL PORTION OF A CATHETER INSIDE THE PACKAGING WITH THE STRAIN RELIEF APPEARING CRACKED AND PORTIONS OF IT MISSING. THERE WERE NO REPORTS OF PATIENT INJURY. IN SUM, 2 OUT OF THE 4 CATHETERS BEING RETURNED HAD THE SAME ISSUES. NONE OF THE CATHETERS WERE USED ON THE PATIENT; ONE WAS OPENED, AND DISINTEGRATION WAS NOTICED BEFORE ACTUAL USE. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO REPORTS OF PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE USER PULLED ALL LOT NUMBERS FROM THE SHELF AND IS SENDING BACK A TOTAL OF FOUR CATHETERS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506039 ↗
• MalfunctionMay 16, 2025Degraded; Degraded

  AS REPORTED, A 5F SUPERTORQUE WITH MARKER BANDS 65CM DIAGNOSTIC CATHETER WAS BEING SHOWN TO A STUDENT, AND BLUE PIECES WERE SEEN. THERE WAS NO REPORTED PATIENT INJURY. THE PIECES WERE SEEN WHILE THE DEVICE WAS STILL IN THE PACKAGE. IT IS DOUBTFUL THE CATHETER WAS MANIPULATED IN A WAY THAT CAUSED THE ISSUE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036637 ↗
• InjuryDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 65CM 8 SIDE HOLES SUPER TORQUE MARKER BAND DIAGNOSTIC CATHETER WAS USED FOR MEASUREMENT AND FOR STENT PLACEMENT AT THE AORTO-ILIAC TARGET LESION. WHEN REMOVING THE DEVICE TO PRACTICE AN ARTERIOGRAM, IT WAS IMPOSSIBLE TO REMOVE IT GENTLY AND THE CATHETER BROKE INTO TWO PIECES INSIDE OF THE PATIENT. THE DEVICE WAS STUCK AGAINST THE WALL OF THE INTRODUCER AND THE AORTO-ILIAC BIFURCATION. THE SEPARATED SEGMENT WAS RETRIEVED WITH AN UNKNOWN GUIDE AT THE LEVEL OF THE ILIAC. THE SURGEON MANAGED TO RECOVER THE SEPARATED END OF THE CATHETER WITHOUT SIGNIFICANT BLOOD LOSS. THIS WAS DURING A PROCEDURE TO PLACE A NON-CORDIS AORTIC STENT WITH ¿BIFURCATED AND STENTS¿ FOLLOWING AN ABDOMINAL AORTIC ANEURYSM. THE SUPER TORQUE CATHETER WAS NOT JAILED BEHIND AN IMPLANTED STENT DURING THIS PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819975 ↗
• MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 65 CM SUPER TORQUE MB PIGTAIL (PIG) ANGIOGRAPHIC CATHETER, SNAPPED IN HALF/SHEARED OFF INSIDE THE BODY. IT WAS SAFELY REMOVED OVER A NON-CORDIS WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANY ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE AND/OR DURING PREP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396158 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED THE GOLD-ALLOY MARKER BANDS DETACHED FROM 5F PIGTAILED 65CM 8 SIDE HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER DURING USAGE. THEY STAYED BLOCKED IN THE SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THE MARKER BANDS DID NOT COME OFF INSIDE THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322284 ↗
• MalfunctionFeb 26, 2024Structural Problem; Structural Problem

  AS REPORTED, THE CALIBRATED MARKERS (1 CM INTERVALS) ON A 5F 65CM 8 SIDE-HOLE (SH) PIGTAIL SUPER TORQUE ANGIOGRAPHIC CATHETER HAD SLIPPED AND MOVED TO THE BASE OF THE CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THIS ISSUE WAS DISCOVERED ON SCREEN WHILE PERFORMING AN ILIAC STENTING DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785527 ↗
• InjuryFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THERE WAS A RUPTURE OF A 5F 65CM 8 SIDE-HOLE (SH) PIGTAIL SUPER TORQUE MARKER BAND (MB) FLUSH CATHETER DURING AN ENDOVASCULAR SURGERY. THE RUPTURE TOOK PLACE INSIDE THE AORTA DURING THE CATHETER CHANGE. THE USE OF A "LASSO" WAS NECESSARY TO EXTRACT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639273 ↗
• InjuryJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PIECE FROM THE 5F 65CM SUPER TORQUE MARKER BAND ANGIOGRAPHIC CATHETER BROKE DURING THE INTERVENTION. THE PART WAS LEFT IN THE PATIENT BETWEEN THE DEPLOYED STENT AND THE ARTERY WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456342 ↗
• MalfunctionOct 24, 2023Structural Problem; Structural Problem

  THE DEVICE WAS DISCARDED AT SITE. A PROCEDURAL CD OR RADIOLOGICAL REPORT IS NOT AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995363 ↗
• MalfunctionSep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 65CM 8-SIDEHOLE (SH) SUPER TORQUE MB ANGIOGRAPHIC CATHETER BROKE NEAR THE MARKERS WHILE ON THE AMPLATZ WIRE. THE PROCEDURE TIME WAS PROLONGED "WHILE PATIENT WAS INTUBATED AT CRITICAL PROCEDURE TIME". THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712326 ↗
• InjuryMay 20, 2022Break; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component

  AS REPORTED, WHILE PERFORMING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON A FEMALE PATIENT, THE SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER (CATH MB 5F PIG 65CM 8SH) WAS PLACED FOR CONTRAST INJECTION PURPOSE BEFORE THE INSERTION OF THE MAIN BODY DEVICE. THE CATHETER WAS PLACED ON A NON-CORDIS STIFF WIRE FROM THE LEFT FEMORAL INTO A NON-CORDIS SHEATH. THE ILIAC ARTERY WAS NOTED AS HEAVILY CALCIFIED. THERE WAS MODERATE VESSEL TORTUOSITY, MILD VESSEL ANGULATION AND NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. WHEN THE PHYSICIAN ATTEMPTED REMOVAL OF THE CATHETER, RESISTANCE WAS FELT, AND A DECISION WAS MADE TO PULL THE CATHETER WITH THE STIFF WIRE TOGETHER. WHEN THE DISTAL PART OF THE WIRE WAS PULLED A FEW CENTIMETERS OUT THEY REALIZED THAT THE DISTAL PART OF THE CATHETER WAS MISSING. THE DISTAL PART OF THE DEVICE WITH THE MARKER BANDS SEPARATED. THE DISTAL PART WAS DETECTED UNDER X-RAY BETWEEN THE ILIAC AND THE AORTA. THE PHYSICIAN PERFORMED A CONTRALATERAL SNARING PROCEDURE AND REMOVED THE SEPARATED PART. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN A STERILE FIELD; IT WAS ALSO STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR US

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463241 ↗
• InjuryOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A CATH MB 5F PIG 65CM 8SH BROKE IN THE SHEATH DURING WITHDRAWAL FROM THE VESSEL. THE CATHETER SHAFT SEPARATED INTO TWO SEPARATE PIECES. A SECOND WIRE WAS INSERTED INTO THE SHEATH AND A BALLOON WAS INSERTED INTO THE SHEATH. THE BALLOON WAS INFLATED, THUS SECURING THE BROKEN CATHETER. EVERYTHING WAS THEN PULLED OUT TOGETHER. THE PROCEDURE WAS COMPLETED BY PLACED A NON CORDIS AAA LIMB IN THE EXTERNAL ILIAC ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE REPORTED EVENT CAUSED NO PATIENT INJURY OR DETERIORATION IN HEALTH. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR REPAIR (EVAR) AND THE CATHETER WAS BEING USED TO MEASURE THE LENGTH OF THE COMMON ILIAC ARTERY. THERE WAS MODERATE CALCIFICATION, MILD TORTUOSITY, MILD ANGULATION, 20% STENOSIS, AND IT WAS NOT A CTO. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE NOR DURING PREP. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). A 14F NON CORDIS SHEATH

  Patient problems: Foreign Body In Patient

  MAUDE report 12574913 ↗
• MalfunctionSep 15, 2021Material Puncture/Hole; Structural Problem; Material Puncture/Hole; Structural Problem

  AS REPORTED, THE MARKERS OF A 5F 65CM 8 SIDE HOLES (8SH) PIGTAIL SUPER TORQUE MARKER BANDS DIAGNOSTIC CATHETER SLIPPED DOWN THE CATHETER WHEN INSIDE THE PATIENT. DURING FAL ANALYSIS, A PUNCTURE/CUT CONDITION WAS FOUND ON THE BODY OF THE UNIT. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475545 ↗
• MalfunctionSep 2, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED BY THE SALES REP, THE DISTAL TIP OR PIG PORTION OF THE 5F 65CM 8 SIDE HOLES (SH) SUPER TORQUE PIGTAIL MARKER BAND (MB) ANGIOGRAPHIC CATHETER SNAPPED OFF AND WAS RETRIEVED BY USING A SNARE. THIS OCCURRED IN THE LEFT ILIAC ARTERY. THE PHYSICIAN WAS PULLING BACK THE CATHETER THROUGH VERY TIGHT SEVERELY CALCIFIED LESION (CLOSE TO A CHRONIC TOTAL OCCLUSION) AND WHEN FELT RESISTANCE TIP OF THE CATHETER SNAPPED OFF IN THE PATIENT. ALSO, A FEW OF THE MARKER BANDS MIGRATED ON THE CATHETER AS WELL. THE DEVICE WAS RETRIEVED WITHOUT DAMAGE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS EXPERIENCED IN USING THE MARKING PIGTAIL CATHETER. THE DEVICE WAS STORED PROPERLY UNDER NORMAL CONDITIONS AND WAS OPENED IN STERILE FILED. NO DAMAGE WAS REPORTED ON THE PACKAGING. THERE WAS NO RESISTANCE/FRICTION WHILE ADVANCING THE CATHETER THROUGH THE SHEATH. THE FEMORAL ARTERY WAS THE ACCESS SITE. RESISTANCE/FRICTION WAS EXPERIENCED WHILE TRACKING/ADVANCING THE CATHETER THOUGH THE VASCULATURE. THE DEVICE DID NOT KINK IN THE AREA OF THE SEPARATION.. THE PATIENT IS CURRENTLY IN GOOD HEALTH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414776 ↗
• MalfunctionAug 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE GOLD COLLARS AROUND A 5F 65CM 8 SIDE HOLES (8SH) SUPER TORQUE MARKER BANDS (MB) DIAGNOSTIC CATHETER SHOULD BE EVERY CENTIMETER, BUT THE SEVERAL ONES NEAR THE MID-PORTION BECAME DETACHED AND CLUMPED UP. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED. PHOTO OF THE DEVICE IS AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294883 ↗
• MalfunctionAug 4, 2021Break

  AS REPORTED, A PART OF A 5F 65CM 8 SIDE HOLES (8SH) SUPER TORQUE MARKER BANDS (MB) DIAGNOSTIC CATHETER SNAPPED INSIDE A PATIENT. THE PHYSICIAN WAS ABLE TO GET IT OUT. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED. PHOTO IS AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273859 ↗
• InjuryMay 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, A 5F 8 SIDE HOLES (8SH) 65CM PIGTAIL SUPER TORQUE DIAGNOSTIC CATHETER BROKE IN THE PATIENT¿S AORTA. THE BROKEN PART WAS REMOVED FROM THE PATIENT WITH DIFFICULTY BY SNARING IT OUT. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. NO ANOMALIES WERE NOTED DURING PREP. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE INTENDED PROCEDURE/TARGET LESION WAS CONTROL IN AAA. THE EVENT CAUSED A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE PATIENTS CURRENT STATUS IS OKAY. A PROCEDURAL CD WAS REQUESTED BUT IS UNAVAILABLE AS WELL AS ADDITIONAL PROCEDURAL DETAILS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852075 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS MODERATE RESISTANCE WHILE WITHDRAWING A 5F 65CM PIGTAIL (PIG) SUPER TORQUE DIAGNOSTIC CATHETER FROM A PATIENT AND THE TIP BROKE OFF INSIDE THE PATIENT¿S AORTA DURING REMOVAL OVER AN UNKNOWN WIRE. THE DEVICE SEPARATED AT 20CM FROM THE DISTAL END AND THE CATHETER TIP WAS RETRIEVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE BEING PERFORMED WAS A AAA REPAIR WITH ENDOGRAFT PLACEMENT. THE ACCESS SITE WAS THE LEFT COMMON FEMORAL ARTERY. IT WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS MODERATE ILIAC ARTERY TORTUOSITY AND MODERATE VESSEL TAKE OFF. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE AND NO ANOMALIES NOTED DURING PREP. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. PROCEDURAL FILMS WERE REQUESTED BUT WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT AVAILABLE. THE LOT NUMBER IS ALSO NOT AVAILABLE AS THE PACKAGING WAS DISCARDED BY THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028055 ↗
• MalfunctionDec 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE MARKER BANDS OF TWO 5F X 65CM SUPERTORQUE CATHETERS MOVE ALONG THE SHAFT OF THE CATHETER AND WERE NOT ATTACHED ANYMORE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AORTO-ILIAC ANEURISM AND SEVERELY CALCIFIED. VESSEL TORTUOSITY WAS ALSO HIGH, AND THE PERCENTAGE OF STENOSIS WAS UNDER 50%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS DISLODGED INSIDE THE PATIENT AT THE SECOND USE OF THE "KT". THE DEVICE WAS PREPPED PROPERLY/NORMALLY, STORED, AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE CATHETER WAS NOT RE-SHAPED BY THE USER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE ARE NO PROCEDURAL FILMS AVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR INSPECTION. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397390 ↗
• MalfunctionOct 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE SUPER TORQUE PIGTAIL MG CATHETER TIP WAS BREAKING. ADDITIONAL INFORMATION WAS RECEIVED AND DURING FAL, IT WAS NOTED THAT THE NON-STERILE CATHETER WAS RECEIVED SEPARATED AT TIP TO BODY FUSE AREA. ALSO, ELONGATIONS COULD BE OBSERVED ON THE SEPARATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240068 ↗
• MalfunctionAug 6, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING USE OF A SUPER TORQUE CATH MB 5F PIG 65CM 8SH A CROSS-OVER INTERVENTION WAS USED, AFTER THE ILIAC ARTERY WAS CATHETERIZED, THE CATHETER GOT STUCK INSIDE OF THE ILIAC ARTERY DURING REMOVAL OF THE DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864213 ↗
• MalfunctionMar 8, 2019Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

  AS REPORTED, TWO 5F SUPER TORQUE MARKER BAND PIGTAIL (65CM 8SH) CATHETER PACKAGES WERE FOUND TO BE NON-SEALED AND WITHOUT STERILIZATION AT THE DISTAL PART OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THE PRODUCT WAS STORED AND HANDLE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS NOT EXPOSED TO LONG PERIODS OF SUNLIGHT. THE HUMIDITY IS NOT CONTROLLED IN THE STORAGE ROOM. AT ANY TIME PRIOR TO USE IN THE CATH LAB, THE DEVICE WAS NOT EXPOSED TO LONG PERIODS OF SUNLIGHT, HIGH TEMPERATURES OR INCREASED HUMIDITY. THE DEVICE WAS NOT PURPOSELY OPENED IN ANTICIPATION OF USE, THEN SHELVED AGAIN WHEN NOT USED. THE DEVICE WAS STORED ON A SHELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405602 ↗
• MalfunctionMar 8, 2019Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

  AS REPORTED, TWO 5F SUPER TORQUE MARKER BAND PIGTAIL (65CM 8SH) CATHETER PACKAGES WERE FOUND TO BE NON-SEALED AND WITHOUT STERILIZATION AT THE DISTAL PART OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THE PRODUCT WAS STORED AND HANDLE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS NOT EXPOSED TO LONG PERIODS OF SUNLIGHT. THE HUMIDITY IS NOT CONTROLLED IN THE STORAGE ROOM. AT ANY TIME PRIOR TO USE IN THE CATH LAB, THE DEVICE WAS NOT EXPOSED TO LONG PERIODS OF SUNLIGHT, HIGH TEMPERATURES OR INCREASED HUMIDITY. THE DEVICE WAS NOT PURPOSELY OPENED IN ANTICIPATION OF USE, THEN SHELVED AGAIN WHEN NOT USED. THE DEVICE WAS STORED ON A SHELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405601 ↗